Expected Launch Timing Remains Unchanged
ST. LOUIS, Oct. 20 /PRNewswire-FirstCall/ -- KV Pharmaceutical Company (NYSE: KVa/KVb) announced today that it was advised by Hologic, Inc., the holder of the New Drug Application (NDA) for Gestiva(TM), that the U.S. Food and Drug Administration (FDA) has extended the PDUFA date on Gestiva(TM) for ninety days from October 24, 2008 to January 25, 2009. The ninety-day extension is in line with the FDA's standard operating procedure when it receives updated data from the applicant seeking the NDA.
Under the terms of the previously announced agreement, KV will acquire ownership of the Gestiva(TM) NDA from Hologic upon payment of KV's final milestone payment of $72.5 million that will become due upon FDA marketing approval for the product and KV's receipt of adequate commercial launch quantities.
KV reiterates that the revised PDUFA date is not expected to impact KV's plans regarding the timing of the launch of Gestiva(TM) during the second half of fiscal 2009.
About KV Pharmaceutical Company
KV Pharmaceutical Company is a fully integrated specialty pharmaceutical company that develops, manufactures, markets, and acquires technology-distinguished branded and generic/non-branded prescription pharmaceutical products. The company markets its technology distinguished products through ETHEX Corporation, a national leader in pharmaceuticals that compete with branded products, and Ther-Rx Corporation, its branded drug subsidiary.
For further information about KV Pharmaceutical Company, please visit the company's corporate website at http://www.kvpharmaceutical.com.
The information in this release may contain various forward-looking
statements within the meaning of the United States Private Securities
Litigation Reform Act of 1995 ("PSLRA") and which may be based on or
include assumptions concerning KV's o
|SOURCE KV Pharmaceutical Company|
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